tbuckley/cabot-search huggingface dataset:
Trends in hematopoietic stem cell transplantation for leukemia, lymphoma and multiple myeloma in the United States: 2016 to 2020.
Authors: Stacy Amadife, Ademola Samuel Ojo, Ahmed Ali
Journal: Journal of Clinical Oncology (2023)

e19059 Background: Hematopoietic stem cell transplantation (HSCT) is a core component of the standard of care for many patients with leukemia, lymphoma and multiple myeloma. We aim to evaluate the trend in HSCT for patients with leukemia, lymphoma, and myeloma in the United States. Methods: This is a retrospective cross-sectional study of transplant activity performed at HSC transplant centers in the United States from January 2016 to December 2020 based on the reports submitted to the Center for International Bone Marrow Transplant Research (CIBMTR). CIBMTR transplant data were evaluated for trends in number of transplant, donor type, cell source and age of patients with leukemia, lymphoma and myeloma who received stem cell transplantation. Results: A total of 87,723 patients with leukemia, lymphoma and myeloma received stem cell transplantation during the study period. The transplant recipients were 0-17 years (4.1%), 18-64 years (66.7%) and ≥ 65 years (29.2%). Indication for the transplantations were multiple myeloma (44.7%), Hodgkin lymphoma (5.5%), non-Hodgkin lymphoma (19.4%), acute lymphoblastic leukemia (8%), acute myeloid leukemia (19.4%), chronic myeloid leukemia (1.4%) and other leukemias (1.5%). Donor types were autologous (64.8%), allogeneic related (16.3%) and unrelated (18.9%). Peripheral blood was the most common cell source (91.6%), followed by bone marrow (6.2%) and cord blood (2.2%). Eighty six percent of all cord blood transplantation were performed for acute leukemias. The total number of transplantation trended up across all disease categories from 2016 to 2019 but slightly declined in 2020. Allogeneic HCT for non-Hodgkin lymphoma and multiple myeloma declined by 11% and 50% respectively between 2016 and 2020. Conclusions: The COVID pandemic has minimal impact on HSCT in the US. HSCT is more commonly performed for myeloma than for patients with lymphoma or leukemia. Most transplants are autologous with peripheral blood as the cell source. There is a progressive decline in the use of allogeneic HSCT for myeloma and non-Hodgkin lymphoma possibly due to emerging novel therapies. [Table: see text]
Perspectives about healthy eating and exercise among patients and providers at the safety-net Lyndon B. Johnson (LBJ) hospital oncology clinic.
Authors: Darya Aleksandrovna Kizub, Margaret Ramsey, Miranda Baum, Hilary Y. Ma, Tejal Amar Patel, Karen Basen-Engquist
Journal: Journal of Clinical Oncology (2023)

e24055 Background: Previous studies have described barriers and facilitators of healthy eating and exercise among cancer patients, but none have done so in a primarily low-income minority population. Understanding the perspectives of patients and providers from safety net hospitals has important implications for optimizing diet and exercise counseling and referral strategies to bridge disparities in cancer care and outcomes. Methods: The population at LBJ hospital is majority Hispanic and Black that are uninsured or underinsured. We conducted semi-structured interviews with patients who were either undergoing or completed cancer treatment at LBJ, as well as with clinic providers, to compare perceived barriers and facilitators of healthy eating and exercise. Interviews were audio-recorded, transcribed, and analyzed via hybrid analysis. Results: Thirty-one patients were interviewed, including 20 (65%) survivors and 11 (35%) who were on active treatment. Twenty-one (68%) were female, 22 (71%) Black, 5 (16%) Hispanic, and 4 (13%) other. Twenty-one healthcare providers were interviewed, including 5 (24%) physicians, 5 (24%) nursing professionals, 4 (19%) dietitians, and 7 (33%) ancillary staff. Barriers to healthy diet and exercise for patients as perceived by providers included lack of knowledge (100%), low access (80%) due to financial difficulties, transportation issues, work and family responsibilities, and low motivation (76%). This resulted in reluctance to counsel patients about healthy living, in part due to anticipated low adherence to recommendations (33%). Most patients could name components of and thought they had a healthy diet (65%), but did not exercise enough (75%) due to cancer-related physical and mental health symptoms (68%). Patients recognized benefits of healthy eating and exercise during and after cancer treatment (32% each) and recalled recommendations from providers about healthy living (48%). Patients voiced high motivation to participate in healthy eating and exercise programming (84%) and follow their medical team’s recommendations (84%), so long as programming was convenient (29%) and included flexibility of multiple options (56%). Patients acknowledged resource-related barriers to healthy living but cited proximity to grocery stores and exercise facilities (84%), help from family in cooking meals (52%), and ability to walk outside or exercise with friends (13%). Conclusions: Despite multiple barriers of capacity, opportunity, and motivation to healthy eating and exercise, cancer patients in a safety-net hospital recognized the importance of healthy living, wanted to participate in such programs, and to get additional information or referrals from their medical team. Based on these results, ongoing studies are evaluating the implementation of referral pathways to healthy living programs for cancer patients at LBJ.
Update on real-world efficacy of anlotinib in non-small cell lung cancer.
Authors: Junzhen Gao, Yan Xu, Yonggang Liu, Li Liang, Yan Yu, Dahai Zhao, Jiahui Jin, Mengzhao Wang
Journal: Journal of Clinical Oncology (2023)

e21173 Background: Anlotinib is a novel oral small molecule TKI with anti-tumor vascular generation and growth inhibition effects, targeting VEGFR, PDGFR, FGFR, and c-kit. It has been shown to be highly effective and low toxicity in the ALTER 0303 study and was approved by NMPA in 2018 for the treatment of NSCLC(non-small cell lung cancer)as third-line and above. Previous studies have shown that anlotinib can benefit patients with advanced NSCLC, especially those in the front-line(first-/second-line). This real-world study aims to update the efficacy of anlotinib in treating NSCLC and to screen the advantage population for anlotinib treatment from front-line/back-line (third-/above-line) treatment, pathological subtype, metastasis site, gene mutation, to provide more effective anlotinib treatment strategies. Methods: This is a multicenter, retrospective, real-world study. Patients with NSCLC who have received anlotinib are included, and subgroup analysis is performed based on pathological subtypes, clinical stages, gene mutations (EGFR mutant/wildtype), front-line/back-line treatments, exploring the impact of different factors on the PFS and OS of NSCLC patients using anlotinib. Results: As of September 2022, a total of 478 patients diagnosed with NSCLC were enrolled in the study, of which 434 were evaluable, with a median age of 63 years, 263 (60.6%) were male, adenocarcinoma in 292 (67.3%), squamous cell carcinoma in 75 (17.3%). At baseline, 59 patients (13.6%) had brain metastasis, 39 (9.0%) had liver metastasis, 127 (29.3%) had bone metastasis, 194 cases (44.7%) had genetic mutations, including 135 cases (31.1%) carrying EGFR mutations. 198 patients (45.6%) received anlotinib as front-line treatment, and 236 patients (54.4%) as back-line treatment. The median follow-up time was 5.09 months (95% Cl, 2.86-7.16), with a mPFS of 4.37 months (95% Cl: 3.78-5.45) in the overall population and a mOS of 20.34 months (95% Cl: 14.88-NA). Among the 138 patients who were evaluable for efficacy, 0 cases achieved complete response (CR), 6 cases partial response (PR), and 57 cases stable disease (SD). ORR was 4.3%, and DCR was 44.9%. The mPFS of front-line was longer than the back-line (5.45 vs 3.52 months), and front-line group had a longer mOS than back-line (NR vs 16.03 months). Subgroup analysis did not find any correlations between pathological subtype or EGFR mutations and patient PFS and OS. However, it was found that the presence of liver and bone metastasis at baseline was related to a shorter OS with anlotinib in the back-line (8.28 vs 16.23 months, p = 0.0253; 7.89 months vs NR, p &lt; 0.001). Conclusions: Anlotinib shows well efficacy in NSCLC patients, prolonging progression-free survival (PFS) and overall survival (OS), especially for front-line patients, suggesting that these patients may be a preferred population for using anlotinib, providing effective evidence for the use of anlotinib treatment for NSCLC patients.
Effect of a telephone-based weight loss intervention (WLI) on weight at 12-months in women with early breast cancer: Results from the Breast Cancer Weight Loss (BWEL) trial.
Authors: Jennifer A. Ligibel, Karla V. Ballman, Linda Mackie McCall, Pamela Jean Goodwin, Anna Weiss, Linda Delahanty, Catherine M. Alfano, Tracy E Crane, Marian L. Neuhouser, Patricia Spears, Dawn L. Hershman, Electra D. Paskett, Judith O. Hopkins, Vanessa Bernstein, Vered Stearns, Julia R. White, Thomas Wadden, Eric P. Winer, Ann H. Partridge, Lisa A. Carey
Journal: Journal of Clinical Oncology (2023)

12001 Background: Obesity is a poor prognostic factor in early breast cancer. The Breast Cancer Weight Loss (BWEL) trial (Alliance for Clinical Trials in Oncology A011401; NCT02750826) evaluates the impact of a WLI on invasive disease-free survival in breast cancer patients (pts) with a body mass index (BMI) ³27 kg/m 2 . Here we report the impact of the WLI on weight change. Methods: Eligible pts were within 14 months of diagnosis of stage 2-3 HER2-negative breast cancer, had completed chemotherapy and radiation (if administered), and were randomized 1:1 to a telephone-based WLI plus health education (HE) or an HE alone control group. The WLI was delivered by telephone-based health coaching and focused on caloric restriction and increased exercise. Height and weight were measured at baseline and 12 months. Changes in weight were compared between groups. Analysis was performed with univariable and multivariable (including arm, baseline weight, menopausal status, race/ethnicity, and hormone receptor [HR] status) regression models. A 0.05 level of significance was used. Results: 3181 women were randomized between 8/2016 and 2/2021. At baseline, mean BMI was 34.5 (±5.74) kg/m 2 , mean age was 53.4 (±10.58) years, and 57% of pts were postmenopausal at the time of diagnosis. 80.3% of participants were White, 12.8% were Black, and 7.3% were Hispanic. Follow-up weight was available from 2293 pts alive and disease-free at 12 months. The WLI led to a significant decrease in weight relative to controls; pts randomized to WLI lost an average of 4.8% (±7.9) of baseline body weight at 12 months vs. 0.8% (± 6.4) weight gain in controls (p&lt;0.0001). Pts randomized to WLI experienced significant weight loss (vs controls) across demographic and tumor factors (Table). WLI effect differed significantly by menopausal status (interaction p value = 0.0057) and race/ethnicity (interaction p-value = 0.019), but not HR status (interaction p-value = 0.17). Conclusions: A telephone-based WLI induced significant, clinically meaningful weight loss in breast cancer pts with overweight and obesity across demographic and tumor factors. Additional tailoring of the WLI could be useful to enhance weight loss in Black and younger pts. Further follow-up of the BWEL trial will evaluate whether the WLI improves disease outcomes. Support: U10CA180821, U10CA180882, UG1CA189823; https://acknowledgments.alliancefound.org . Clinical trial information: NCT02750826 . [Table: see text]
Risk of malnutrition and predisposing factors among Mexican patients with advanced cancer.
Authors: Sergio Contreras, Alfredo Covarrubias-Gómez, Wendy Alicia Ramos-Lopez, Araceli Carrillo-Bedoya, Roberto Gonzalez Salazar, Ilana De la Puente-Tawil, Andrea Morales Alfaro, Montserrat Amaya Caballero, Laura Kay Lagarde-Santillán, Gloria Lizbeth Ramos-Ruelas, Jaziel Simón Acevedo-Silva, Maria del Pilar Milke Garcia, María Fernanda Esparza-Orozco, Enrique Soto Pérez de Celis, Yanin Chavarri Guerra
Journal: Journal of Clinical Oncology (2023)

12033 Background: Malnutrition is a predictor of cancer survival independent of cancer site. However, routine screening for malnutrition is underutilized. Advanced cancer accounts for 60% of cancer cases in developing countries of which approximately 52 % have malnutrition. This study aimed to describe factors associated with risk of malnutrition among patients with advanced cancer. Methods: We conducted a cross-sectional analysis of baseline data from patients with recently diagnosed advanced cancer included in a multidisciplinary patient navigator-led supportive care program in Mexico City (Te Acompañamos). At the time of enrollment in the program, patients completed a series of questionnaires including assessments of quality of life (FACT-G), various symptoms and the validated malnutrition screening tool (MST). Clinic and demographic characteristics were obtained from the patient chart. Descriptive statistics were used for analysis and factors associated with risk of malnutrition were analyzed by bivariate testing. Results: Between August 2017 and December 2022, a total of 601 patients were included. Mean age was 62 years (range 18-94), 57.2% were women, 56% had gastrointestinal and 28% gynecological malignancies. 72 % screened positive for malnutrition on the MST and 49 % reported nausea on FACT-G. Patients with an ECOG performance status ≥3 were more likely to screen positive for malnutrition (OR 5.9 95%CI 2.5- 13) as well as those with baseline nausea (OR 2.99; 95%CI 1.9-4.7). On the other hand, patients with active chemotherapy (OR 1.4 95%CI, 1.016-1.95) and those receiving antiemetic treatment with a single medication (OR 1.63 95%CI, 1.1-2.4) were more likely to have nausea. No other clinical or demographic characteristics were significantly associated with screening positive for malnutrition or reporting nausea, including gender, age, history of smoking or alcohol abuse, type of neoplasia, or oncologic treatment. Conclusions: Our results show that a high proportion of patients with advanced cancer are at increased risk for malnutrition and report nausea. Poor functional status and nausea were strongly associated with a higher risk of malnutrition, while receiving insufficient antiemetic medication was associated with increased odds of nausea. This suggests that appropriate treatment of nausea and nutritional interventions should be prioritized early in the management of patients with advanced cancer regardless of the type of cancer treatment in order to avoid malnutrition and improve patient well-being.
Patient- versus clinician-reported symptoms in the POLARIX study.
Authors: Carrie A. Thompson, Neha Mehta-Shah, Christopher Flowers, Gilles A. Salles, Herve Tilly, Neil Sun Chua, René-Olivier Casasnovas, Fiona Miall, Tae Min Kim, Cheng-Hong Tsai, Sunita Dwivedy Nasta, Seung Tae Lee, Veronica Craine, Avrita Campinha-Bacote, Jamie H. Hirata, Calvin Lee, Matthew Dean Sei Sugidono, Jonathan W. Friedberg
Journal: Journal of Clinical Oncology (2023)

12100 Background: The safety profiles of novel agents are mainly based on clinician-reported adverse events (AEs) from clinical trials. Patient-reported outcomes (PROs) may better represent the treatment burden experienced by patients (pts) compared with clinician-reported AEs. Using data from POLARIX, a double-blind, placebo-controlled, randomized Phase 3 international study (NCT03274492), we previously presented PRO and clinician-reported data showing similar rates of neuropathy (Trněný et al. 2022). Here, we evaluate the reporting of other common symptoms using PRO and clinician-reported data in POLARIX. Methods: POLARIX methods were previously described (Tilly et al. 2022); this analysis included all pts with PRO data. PRO and clinician-reported data described the incidence and severity of fatigue, constipation, diarrhea, nausea, and vomiting. Clinician-reported severity grading was based on the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0. PROs were collected using the European Organisation Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30), which was administered to pts at clinic visits on Day 1 of Cycles 1 (baseline), 2, 3, and 5, and end of treatment (EOT). PRO severity scores included ‘A little’, ‘Quite a bit’, and ‘Very much’. Results: Overall, 825 pts were evaluable. From baseline to EOT, PROs showed a higher incidence of symptoms compared with clinicians for fatigue (98% vs 27%), constipation (68% vs 29%), diarrhea (56% vs 26%), nausea (58% vs 40%), and vomiting (24% vs 15%). PRO severity scores of ‘Quite a bit’ or ‘Very much’ were reported in 33% of pts for fatigue, 29% for constipation, 17% for diarrhea, 19% for nausea, and 7% for vomiting. Clinicians reported Grade ≥2 symptoms in 11% of pts for fatigue, 11% for constipation, 11% for diarrhea, 14% for nausea, and 6% for vomiting. Conclusions: In POLARIX, pts reported a higher incidence and severity of symptoms compared with clinicians. Although distinct scales were used, the differences in symptom rates reported by pts and clinicians were clinically meaningful. These data may have implications for symptom management, including physician evaluation and communication of symptom expectations for pts. Reporting of symptoms by PROs should be incorporated into clinical trials as an adjunct to standard AE reporting to better characterize the patient experience. Clinical trial information: NCT03274492 . [Table: see text]
Polygenic risk score calibration and association with breast cancer in diverse ancestries.
Authors: Matthew Kucera, Elisha Hughes, Brent Mabey, Brooke Hullinger, Holly Jane Pederson, Tuya Pal, Susan M. Domchek, Charis Eng, Judy Ellen Garber, Ora Gordon, Jennifer R. Klemp, Semanti Mukherjee, Joseph Vijai, Sandhya Pruthi, Allison W. Kurian, Pat W. Whitworth, Jerry Lanchbury, Thomas Paul Slavin, Alexander Gutin, Olufunmilayo I. Olopade
Journal: Journal of Clinical Oncology (2023)

10505 Background: Polygenic risk scores (PRS) have been shown to substantially improve breast cancer (BC) risk prediction when incorporated into traditional risk assessment models. However, PRS developed primarily in women of European ancestry have shown poor performance when applied to non-European populations. We previously described development and validation of a multiple-ancestry PRS (MA-PRS) that is based on individual ancestral genetic composition. MA-PRS has been incorporated into the Tyrer-Cuzick model for use in clinical practice and has been shown to provide independent value to the model. Here, we describe performance of the MA-PRS in a large cohort of women from diverse ancestral backgrounds. Methods: The study cohort included 203,586 patients who were referred for hereditary cancer testing and negative for pathogenic variants in genes associated with BC. MA-PRS was calculated as previously described based on 149 SNPs (93 BC and 56 ancestry-informative). Association of MA-PRS with invasive BC status (affected vs unaffected) was analyzed using logistic regression adjusted for personal and family cancer history, age, and ancestry. Calibration was assessed by examining the MA-PRS distribution within unaffected patients, and through goodness-of-fit tests. All analyses were conducted within the full cohort and within ancestral subpopulations. Odds ratios (ORs) are reported per standard deviation. Results: One-fifth (43,782/203,586, 21.5%) of patients were diagnosed with invasive BC, and 60,657 (29.8%) of patients reported BC in a first degree relative. The MA-PRS distribution was centered around zero among unaffected patients overall and within each subpopulation. MA-PRS significantly improved BC risk prediction over clinical factors in the full cohort (OR = 1.43, 95% CI:1.41-1.44) and within each ancestral subpopulation (Table). The strongest associations were observed in Ashkenazi Jewish (OR = 1.56, 95% CI:1.39-1.76) and South Asian (OR = 1.49,95% CI: 1.23-1.81) populations. The top decile of the MA-PRS consistently identified patients with two-fold increased risk of developing BC. Goodness-of-fit tests showed that the MA-PRS was well calibrated and predicted BC risk accurately in the tails of the distribution for both European and non-European women. Conclusions: The breast cancer MA-PRS based on genetic ancestral composition is well-calibrated and strongly associated with BC in all tested ancestral populations. Incorporation of PRS adds independent information to risk models and supports equitable access to personalized BC risk management. [Table: see text]
Meta-analysis of efficacy outcome measures across immune checkpoint inhibitors (ICIs) and targeted therapies (TTs) in melanoma to guide future clinical trial design.
Authors: James Ousey, Sima Ahadieh, Alessandra Di Pietro, Keren Sturtz, Jason H. Williams, Gerald Fetterly
Journal: Journal of Clinical Oncology (2023)

e21520 Background: Systemic treatments (Tx) for unresectable or metastatic melanoma include TTs and ICIs, with TT+ICI combinations under exploration. Heterogeneity in clinical trial sample size and subject characteristics pose obstacles for treatment class comparisons. We applied meta-analysis to elucidate Tx and covariate effects on efficacy outcomes in melanoma. Methods: A PICOS-guided literature search was conducted from 2000-2022 for TT or ICI given as monotherapy or in combination for unresectable or metastatic melanoma. Median progression-free survival (mPFS), median overall survival (mOS), and overall response rate (ORR) were recorded. Random-effects models were fit to endpoints with study arms weighted by variance. Covariate inclusion was based on likelihood-ratio tests (P &lt; 0.05). For simulation, parameter distributions from weighted linear regression (w i ~ n study ) of mPFS to ORR were sampled (N = 5000) with residual error scaled by mean Phase 3 arm size. ORR uncertainty was modeled by normal approximation. Results: From 134 publications, 100 (mPFS), 73 (mOS), and 111 (ORR) outcomes were retained, from 53, 44, and 63 studies, respectively, and classified by treatment. For all endpoints, Tx classification was an outcome predictor (P&lt; 0.001). BRAFi+MEKi+PD-1 combination therapy had the greatest predicted duration of mPFS (16.7 months [11.8, 23.6]) and ORR (62.8% [53.7%, 71.1%]). mPFS and mOS outcomes were reduced by prior Tx failure and evidence of brain metastases, with mOS also impacted by elevated lactate dehydrogenase. I 2 statistics for the final models were 89.0% (mPFS), 73.9% (mOS), and 51.8% (ORR). A robust correlation between ORR and mPFS (R 2 = 0.77, P &lt; 0.001) was observed across all treatment classes. The predictive power of this relationship was demonstrated by simulating the probability of achieving target Phase 3 mPFS outcomes from ORR derived from as few as 20 patients. Conclusions: This meta-analysis characterizes the shifting space of Tx in unresectable or metastatic melanoma and provides a model-based framework for simulation of efficacy endpoints and trial designs for TT+ICI combinations. ORR-based predictions of trial success illustrate the value of utilizing early endpoints to inform decisions in drug development, across all Tx options in melanoma. Further investigation will include longitudinal PFS and OS modeling and refinement of PFS predictions from tumor growth metrics and clinical benefit rate.